Access CMV IgM, Calibrators

by Beckman Coulter Inc. United States EUDAMED

Ref A40706

EMDN W0105080904

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-A40706U2 Basic UDI-DI	Date13 Jun 2022Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: A40706

Primary DI / UDI-DI: D-A40706U2
Basic UDI-DI: B-A40706U2
EMDN Code: W0105080904 Other virology standards and calibrators - inf.imm.

Device Class: Class IVD Annex II List B
Market of Registration: Ireland

Manufacturer details

EUDAMED SRN: US-MF-000010288
Authorised representative: Beckman Coulter Ireland Inc. IE-AR-000000886

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Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Reagent
Professional Testing

Other properties (7)

Sterile: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED bb4d79a0-5046-4dd5-a4e3-6490eb706d2f 61 fields · synced 22 Oct 2026